BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4875134 · Received June 29, 2015

    Report

    Report Number
    2520274-2015-14669
    Event Type
    Injury
    Date Received
    June 29, 2015
    Report Date
    June 23, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. RING, DAVID., TAVAKOLIAN JASON., KLOEN PETER., HELFET, DAVID AND JUPITER JESSE. (2004). LOSS OF ALIGNMENT AFTER SURGICAL TREATMENT OF POSTERIOR MONTEGGIA FRACTURES: SALVAGE WITH DORSAL CONTOURED PLATING. J HAND SURG, 29A, 694¿702. THIS REPORT IS FOR AN UNKNOWN (PLATE) /UNKNOWN QUANTITY/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE RING, DAVID., TAVAKOLIAN JASON., KLOEN PETER., HELFET, DAVID AND JUPITER JESSE. (2004). LOSS OF ALIGNMENT AFTER SURGICAL TREATMENT OF POSTERIOR MONTEGGIA FRACTURES: SALVAGE WITH DORSAL CONTOURED PLATING. J HAND SURG, 29A, 694¿702. THE PURPOSE OF THIS ARTICLE WAS TO REVIEW THE RESULTS OF INTERNAL FIXATION WITH A DORSAL CONTOURED PLATE IN PATIENTS WITH MALALIGNMENT AFTER INTERNAL FIXATION OF A POSTERIOR MONTEGGIA FRACTURE. SEVENTEEN PATIENTS WITH MALALIGNMENT AFTER SURGICAL TREATMENT OF A POSTERIOR MONTEGGIA FRACTURE WERE TREATED WITH REALIGNMENT OF THE ULNA AND FIXATION WITH A CONTOURED DORSAL PLATE. FIFTEEN PATIENTS HAD LOOSE FIXATION AND 12 PATIENTS HAD SUBLUXATION OR DISLOCATION OF THE ULNOHUMERAL JOINT. SIXTEEN PATIENTS HAD FRACTURE OF THE RADIAL HEAD AND 9 PATIENTS HAD FRACTURE OF THE CORONOID PROCESS. NINE PATIENTS HAD ANCILLARY PROCEDURES ON THE RADIAL HEAD, 4 HAD ANCILLARY PROCEDURES ON THE CORONOID, 5 HAD HINGED EXTERNAL FIXATION, AND ONE HAD FASCIAL ARTHROPLASTY. SEVEN PATIENTS HAD ANOTHER SURGERY BEFORE THE FINAL EVALUATION RELATED TO A COMPLICATION IN 6 PATIENTS AND A TO SUBSEQUENT INJURY IN 1 PATIENT. SEVENTEEN PATIENTS WERE TREATED BETWEEN 1990 AND 2000. THERE WERE 7 MEN AND 10 WOMEN WITH AN AVERAGE AGE OF 49 YEARS (RANGE, 25¿74 YEARS). A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 6 OF 6 FOR COM #(B)(4). THIS REPORT IS FOR AN UNKNOWN PLATE AND REFERS TO PATIENT 7, ((B)(6) YEAR, MALE), WHO POST-OPERATIVE SUSTAINED A COMPLEX ARTICULAR FRACTURE OF THE DISTAL HUMERUS AFTER 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418146 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention